Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02232451
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2012-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique
Sponsor:
Azienda Ospedaliera San Paolo
Organization:
Study Overview
Official Title:
Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
loop
Brief Summary:
The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.
Detailed Description:
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients.
Type of study: Multicentric, prospective and randomized trial
Patients: PEP high-risk patients underwent ERCP for benign biliary pathology
Number of patients: 320 patients (160 for each group)
Aim:
Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.
Type of study: Multicentric, prospective and randomized trial
Patients: PEP high-risk patients underwent ERCP for benign biliary pathology
Number of patients: 320 patients (160 for each group)
Aim:
Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: